Kodak Directview Dr 3000 System 64KW/80KW Generators, Models 6551345, 6551386

• • Terminated Z-0806-2020 FDA Class II ·initiated 6 Jan 2020

  Carestream Health has discovered a potential safety problem that can lead to unintended movement of the U-Arm.

• • Terminated Z-0731-2008 FDA Unclassified (pre-2012) ·initiated 21 Dec 2007

  Unintended Positioner Movement - The U-Arm Positioner starts to move 1) without command from the operator and/or 2) can unexpectedly start movement if the system is powered down and re-energized after a collision has occurred with the Quantum Table.

• • Terminated Z-0717-2007 FDA Unclassified (pre-2012) ·initiated 6 Mar 2007

  The x-ray systems do not indicate the field size when the system's detector is turned off and the collimator is in manual mode. This results in the systems being noncompliant with the field indication performance standards of section 1020.31(e)(2)& (3) of 21Code of Federal Regulations (CFR).

510(k) Number

K060550 ↗

FDA Product Code

KPR

Device Class

Class II

Regulation

21 CFR Part 892.1680

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

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